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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 207745

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NDA 207745 describes NITROGLYCERIN, which is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Encube, Tp Anda Holdings, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon Research, Sigmapharm Labs Llc, Viwit Pharm, and Baxter Hlthcare, and is included in thirty-five NDAs. It is available from twenty-eight suppliers. Additional details are available on the NITROGLYCERIN profile page.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.

Summary for 207745

Tradename:	NITROGLYCERIN
Applicant:	Sigmapharm Labs Llc
Ingredient:	nitroglycerin
Patents:	0

Medical Subject Heading (MeSH) Categories for 207745

Explosive Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	0.3MG
Approval Date:	May 7, 2018	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	0.4MG
Approval Date:	May 7, 2018	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;SUBLINGUAL			Strength	0.6MG
Approval Date:	May 7, 2018	TE:		RLD:	No

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